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临床试验/NCT01183351
NCT01183351已完成不适用

Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia

Sykehuset Innlandet HF2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)

研究概览

简要总结

The increasing prevalence of dementia is a major challenge to the health authorities in most countries. Nearly all the persons suffering from dementia experience behavioural and psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes. BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal and the risk of serious adverse events is considerable. All the major treatment recommendations advise that non-pharmacological measures should be applied first when treating BPSD even though the evidence for such treatment is limited. The investigators will conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been developed in Norway and has already been implemented in a number of nursing homes in the county of Nordland.

详细描述

Intervention description:

Initially the intervention group will receive education about dementia, BPSD, quality of care and use of psychotropic drugs Subsequently, staff in the nursing home will receive training in the intervention method: MID. Two or three nurses from each nursing home will receive more intensive training in the method to ensure effective implementation of the method in daily practice. After this initial period that will last for four weeks, trained research nurses will visit each nursing home every fortnight ensuring that the intervention is properly implemented and thereby assure adherence to the treatment protocol.

Description of the intervention Multidisciplinary Intervention model for challenging behaviour in Dementia, MID, consists of three stages: a registration-observation stage, a staff guiding stage, and an evaluation stage.

  1. Registration-observation stage:

The nurses use a daily registration sheet for the actual types of behaviour that are challenging. This ensures that the behaviour is properly observed on a daily basis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients are eligible for inclusion if they have a possible or probable dementia diagnosis and clinically significant agitation score 6 or higher (as measured by the CMAI: Cohen-Mansfield Agitation Behaviour
  • A permanent stay in nursing home of at least 4 weeks
  • Given verbal or written assent for participation or has written consent given on their behalf by their next of kin

排除标准

  • Lack of consent, terminal state,unremitting pain.

结局指标

主要结局

Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)

时间窗: 8 months

次要结局

  • Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).(8 months)
  • Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)(8 months)
  • Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life(8 months)
  • Use of antipsychotic drugs(8 months)
  • The Cornell scale for depression in dementia (CSDD)(8 months)
  • Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour(8 months)
  • Staff measures:P-cat:Person-centered Care Assessment Tool(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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